There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
PTSD is a mental disorder including psychological symptoms related to severe traumatic event(s). PTSD can negatively affect people's functioning in several life domains. Several effective therapies for the treatment of PTSD have been developed in recent decades. However, these treatments are not effective for every patient. Several studies show that people suffering from PTSD also experience feelings of trauma-related guilt, shame, self-blame and negative self-evaluation. These emotions may contribute to the maintenance cycle of PTSD or even become worse over time. In particularly in patients with trauma who have been exposed to repeated traumatic experiences within the context of interpersonal relationships including childhood sexual/physical abuse and domestic violence. This type of trauma is known as complex PTSD. cPTSD is marked by severe difficulties in problems with self and emotion-regulation, relationship difficulties and shame. One key factor for reducing self-criticism in individuals might be self-compassion as the antidote to self-criticism and shame. Compassion focused therapy by Paul Gilbert focuses specifically on increasing self-compassion. Although some studies show promising results of CFT in patients with cPTSS, the effectiveness for this group has not yet been sufficiently examined. Therefore, this Single case experimental design study is conducted with the primary objective of examining the effectiveness of CFT in reducing the primary outcome self-criticism. Secondary outcomes that will be examined are CFT reduces PTSD symptoms and shame and increases self-compassion and well-being. This SCED study is a noncurrent multiple baseline across subjects study, consisting of three phases with twice-weekly repeated measurements of self-criticism. First the pre-intervention baseline phase, in which participants are randomly assigned to different baseline lengths (either 5, 6 or 7 weeks). The second phase is the subsequent CFT-intervention, consisting of 12 weeks of weekly CFT group sessions with two-weekly assessments of self-criticism. The third phase is follow up for 5 weeks from the end of the intervention, again including two-weekly assessments of self-criticism. By comparing the baseline phases with the intervention and follow-up phases for individual participants, the effectiveness of the CFT intervention on self-critical beliefs can be determined. Changes that occur within participants can be seen as evidence of intervention effectiveness.
This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.
The ReDUCE Trial is a multinational single-blinded randomized controlled trial in mild to moderate flare of Ulcerative colitis (UC) disease patients. The purpose of the study is to validate the clinical efficacy of the UCED (Ulcerative colitis Exclusion Diet) with partial enteral nutrition (PEN) using a novel formula. The investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.
In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed/refractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the phase II trial.
The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders. The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.
The increased cultural diversity in client populations in mental healthcare settings led to the addition of the Cultural Formulation Interview (CFI) in the Diagnostic and Statistical Manual for Mental Disorders (DSM-5). The CFI aims to clarify clients' vision, experiences, and context to improve communication about cultural backgrounds, increase mutual understanding and rapport, and prevent cultural misunderstandings. Empirical evidence of this effect in clinical practice is still lacking. This study investigates whether the CFI influences the therapeutic working alliance between a client with a migration background and a clinician, and the informant version of the CFI (CFI-I) influences the relationship between a client's informant and a clinician, focusing on the role of perceived cultural empathy as moderator, or mediator in this interaction. A Cluster-Randomized Controlled Trial (RCT) will be performed among clients with a migratory background in four mental healthcare centers in the Netherlands. The participants in this study are adults with a migratory background, aged 18 years and older, their informants, and clinicians. Participants were randomly assigned into two groups. In the intervention group, the CFI and CFI-Informant version (CFI-I) were used shortly after admission and intake, and the control group received a clinical assessment as usual. Included informants were assessed with the CFI-I or hetero-anamneses by the participating clinicians. The main outcome measure is the work alliance between clients and their clinicians. This will be evaluated using the Work Alliance Questionnaire. Perceived cultural empathy as a potential mediator or moderator will be measured with the Barrett-Lennart Relationship Inventory among clients and informants, and the Scale of Ethnocultural Empathy among clinicians. The clients and informants will be randomly assigned to the intervention group or the control group. They will all fill out a questionnaire about perceived cultural empathy after the first, and two questionnaires about work alliance, and perceived cultural empathy after five treatment sessions. The clinicians will perform the clinical assessments with or without the CFI and fill out a questionnaire about self-perceived cultural empathy after the first session and two questionnaires about work alliance and cultural empathy after a maximum of five given treatments. There is no physical, behavioral, or medical intervention included in the research protocol.
In standard of care regularly planned surgery, tissue will be obtained from patients who are suspicious for having vestibular Schwannoma (on MRI). The tissue that remains after the pathologist gathered sufficient for analysis, the remaining tissue is used for creating tumour stem cell organoids.
This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use. The study will also be comparing 200 mg with 100 mg filgotinib a day to see if the lower dose also helps to treat axSpA.